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Guselkumab for Psoriatic Arthritis (SOLSTICE Trial)
SOLSTICE Trial Summary
This trial will evaluate whether the drug guselkumab is effective in treating psoriatic arthritis in people who have not responded well to other treatments.
SOLSTICE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSOLSTICE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 1027 Patients • NCT03573323SOLSTICE Trial Design
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Who is running the clinical trial?
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- I have active psoriasis with a plaque of 2cm or larger, nail changes, or a history of plaque psoriasis.I have active psoriasis with a plaque of 2cm or larger, nail changes, or a history of plaque psoriasis.I have been diagnosed with psoriatic arthritis for at least 6 months.My PsA did not improve or worsened with TNF alpha treatment.I have PsA affecting my joints without rheumatoid nodules.I have PsA and didn't respond well to my first TNF alpha blocker treatment.I have PsA affecting my fingers, many joints, or spine with joint pain.My PsA did not improve or worsened with TNF alpha treatment.I have PsA with at least 3 swollen and 3 tender joints, and my CRP level is >= 0.3 mg/dL.I have PsA affecting my fingers, many joints, or spine with joint pain.
- Group 1: Group 1: Guselkumab and Placebo
- Group 2: Group 3: Placebo Followed by Guselkumab
- Group 3: Group 2: Guselkumab
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has this kind of experiment been done before?
"As of now, there are 21 ongoing clinical trials for Guselkumab in 282 different cities and 57 countries. The first trial was completed in 2018 by Janssen Research & Development, LLC. A total of 1406 patients were involved and the study reached Phase 2 & 3 during the drug approval process. In the years since 2018, 18303 more trials have been carried out."
What have researchers found in terms of the safety of Guselkumab?
"There is some evidence that Guselkumab is effective and multiple rounds of data collected thus far support its safety; we rate it a 3."
How many people are currently enrolled in this study?
"That is correct, the clinical trial was posted on September 28th, 2021 and is actively searching for patients. The most recent update to the information was made on October 6th, 2022. They are looking for a total of 450 participants from 53 different locations."
Where can people go to participate in this clinical trial?
"The 53 active clinical trial sites for this study are geographically dispersed, with The Woodlands, Huntington Beach and Birmingham being a few of the many locations. To reduce travel burden, patients are encouraged to enroll at the nearest site."
Can you tell me if Guselkumab has been researched before?
"There are currently 21 trials involving Guselkumab, with 7 in Phase 3. Many of these studies originate from Milan and Kansas, but there are 2682 clinical trial locations for Guselkumab globally."
Is this study still looking for more participants?
"Yes, this is an ongoing trial that is still looking for enrollees. According to the information on clinicaltrials.gov, the data was originally posted on September 28th, 2021 and updated as recently as October 6th, 2022. There are 450 spots available at 53 different sites."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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